CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 278 enrolled
Drug / intervention
Optimal Medical Management (OMM) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01697358
NCT01697358Phase 4Completed
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Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain

MedtronicNeuro·interventional·Posted Oct 2, 2012·Updated Jul 21, 2017

In Brief

A Phase 4 clinical trial evaluating Spinal Cord Stimulation (SCS) and Optimal Medical Management (OMM) for Failed Back Surgery Syndrome and 2 related conditions. Completed, enrolled 278 participants across 28 sites in 9 countries.

Detailed Summary

The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering from predominant low back pain due to failed back surgery syndrome (FBSS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFailed Back Surgery Syndrome, Back Pain, Pain in Leg, Unspecified
CountriesBelgium, Canada, Colombia, France, Germany, Netherlands, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 2, 2012
Enrollment StartJan 8, 2013
Primary CompletionMar 12, 2016
Study CompletionJun 20, 2017
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 13.8 years ago

Interventions

Spinal Cord Stimulation (SCS)device

Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead. Subjects will undergo an SCS screening test and, if successful, an implantable neurostimulation system implant. Any SCS group subject not implanted will continue to be treated with OMM and will be followed as part of the SCS group.

Optimal Medical Management (OMM)drug

The investigator and subject will determine an individual OMM treatment plan, which should include non-investigational pharmacologic agents and/or therapies.